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NCT00231842 · OUTCOME

Cycles With Hematologic Toxicities

Adjuvant Radiation Therapy With Ifosfamide in Patients With Mixed Mesodermal Tumors of the Uterus · Source last updated 2019-01-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Cycles
Interval / dispersion
Not reported
Time frame
2 years

What was measured

Out of 162 planned cycles, a total of 138 cycles (85%) were administered. Number of cycles during which participants with grades 3 and 4 experienced hematologic toxicities are reported. Most of the toxicities were self-limiting.

Groups in this outcome

Grade 3 Toxicity

Adjuvant Radiation Therapy "Sandwiched" between Ifosfamide in Patients with Mixed Mesodermal Tumors Ifosfamide: Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. Radiation Therapy: Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles.

Grade 4 Toxicity

Adjuvant Radiation Therapy "Sandwiched" between Ifosfamide in Patients with Mixed Mesodermal Tumors Ifosfamide: Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Grade 3 Toxicity27
Grade 4 Toxicity27

Reported measurements

Neutropenia
Values in Cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 3 Toxicity11Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity14Not reportedNot reportedNot reportedNot reported
Anemia
Values in Cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 3 Toxicity6Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity0Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in Cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 3 Toxicity6Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        14
    title
    Neutropenia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        0
    title
    Anemia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        2
    title
    Thrombocytopenia
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      27
    units
    Participants
description
Out of 162 planned cycles, a total of 138 cycles (85%) were administered. Number of cycles during which participants with grades 3 and 4 experienced hematologic toxicities are reported. Most of the toxicities were self-limiting.
groups
  1. description
    Adjuvant Radiation Therapy "Sandwiched" between Ifosfamide in Patients with Mixed Mesodermal Tumors Ifosfamide: Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. Radiation Therapy: Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles.
    id
    OG000
    title
    Grade 3 Toxicity
  2. description
    Adjuvant Radiation Therapy "Sandwiched" between Ifosfamide in Patients with Mixed Mesodermal Tumors Ifosfamide: Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles.
    id
    OG001
    title
    Grade 4 Toxicity
param Type
NUMBER
reporting Status
POSTED
time Frame
2 years
title
Cycles With Hematologic Toxicities
type
PRIMARY
unit Of Measure
Cycles

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice